Washington DC (USA) Oct 16: The U.S. Food and Drug Administration (FDA) has announced that it will hold an advisors' meeting in late November to scrutinize Merck and Ridgeback's investigational oral antiviral pill to treat COVID-19.
The Antimicrobial Drugs Advisory Committee of the FDA will meet on Nov. 30 to discuss the available data supporting the use of molnupiravir, the investigational drug to treat mild-to-moderate COVID-19 in adults who have tested positive, and who are at high risk for progression to severe COVID-19, including hospitalization or death, the FDA said Thursday.
"The FDA is evaluating the safety and effectiveness data submitted by Merck and Ridgeback in their emergency use authorization (EUA) request for molnupiravir, a new oral treatment for high-risk individuals with a newly diagnosed COVID-19 infection," said Patrizia Cavazzoni, director of the FDA's Center for Drug Evaluation and Research.
A public discussion of these data with the agency's advisory committee will help ensure clear understanding of the scientific data and information that the FDA is evaluating to make a decision about whether to authorize this treatment for emergency use, Cavazzoni said.
It marks the first time the FDA has convened its expert advisors before ruling on a coronavirus treatment.
The FDA said the meeting was scheduled as soon as possible following Merck's request. The November date will allow agency scientists to review the application ahead of the meeting, the agency said.
Merck and Ridgeback filed an EUA application for molnupiravir to the FDA on Monday. Interim analysis from a Phase 3 clinical trial shows molnupiravir reduced the risk of COVID-19 hospitalization or death by approximately 50 percent, according to the companies.
Source: Xinhua
